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HemosIL Factor X Deficient Plasma is human plasma immunodepleted of Factor X and intended for the in vitro diagnostic quantitative determination of Factor X activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems.

HemosIL Factor X Deficient Plasma is human plasma immunodepleted of Factor X and intended for the in vitro diagnostic quantitative determination of Factor X activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems.

Abnormalities of the extrinsic pathway factors are determined by performing a modified prothrombin time (PT) test. Patient plasma is diluted and added to a plasma deficient in Factor X. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the Factor X in the patient plasma, interpolated from a calibration curve.

Acceptance Criteria and Study for HemosIL Factor X Deficient Plasma

This document describes the acceptance criteria and the study that demonstrates the HemosIL Factor X Deficient Plasma device meets these criteria, as derived from the provided 510(k) summary (K031122).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the performance metrics presented for substantial equivalence to predicate devices. These criteria are based on method comparison (slope and correlation coefficient) and precision (within-run and between-run coefficient of variation).

vs. Predicate IL Test Factor X Deficient Plasma on ACL Family:
ACL 3000 (n=62): Slope = 1.0328, r = 0.9849
ACL Futura (n=62): Slope = 1.0680, r = 0.9840 |
| Slope | A slope close to 1.0 (indicating proportional agreement) | A slope close to 1.0 (indicating proportional agreement) | Demonstrated to be close to 1.0 across different systems and predicates (e.g., 0.9461 to 1.0680). |
| Correlation Coefficient (r) | A high correlation coefficient (typically ≥ 0.975 as a common standard for method comparison in IVDs) | A high correlation coefficient (typically ≥ 0.975) | Demonstrated to be high across different systems and predicates (e.g., 0.9840 to 0.9948). |
| Within Run Precision| (Not explicitly stated for predicate in this summary, but typically a low CV% is expected for IVDs) | (Not explicitly stated for predicate in this summary, but typically a low CV% is expected for IVDs) | CV% for Normal Control: Low (e.g.,

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HemosIL Factor VII Deficient Plasma is human plasma immunodepleted of Factor VII and intended for the in vitro diagnostic quantitative determination of Factor VII activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems.

HemosIL Factor VII Deficient Plasma is human plasma immunodepleted of Factor VII and intended for the in vitro diagnostic quantitative determination of Factor VII activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems. Abnormalities of the extrinsic pathway factors are determined by performing a modified prothrombin time (PT) test. Patient plasma is diluted and added to a plasma deficient in Factor VII. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the Factor VII in the patient plasma, interpolated from a calibration curve.

Here's a breakdown of the acceptance criteria and study information for the HemosIL Factor VII Deficient Plasma device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device demonstrates substantial equivalence rather than meeting explicit acceptance criteria in the traditional sense of pre-defined thresholds. The performance is compared directly to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Method Comparison: 60 citrated plasma samples (30 normal / 30 abnormal)
• Sample Size for Precision: The text states "multiple runs (n=80)" using two levels of control. This means 80 measurements were taken for each control level on each instrument for the precision study.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be retrospective measurements of samples (either previously collected or prepared for the study), as opposed to prospective collection specifically for this study. The phrasing "evaluating 60 citrated plasma samples" and "using two levels of control" suggests existing or prepared samples within a laboratory setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this device and study. The device is for quantitative determination (measuring Factor VII activity), not for diagnostic interpretation by human experts. The "ground truth" for method comparison and precision studies typically relies on the established accuracy and precision of the predicate device and the known concentrations of control materials.

4. Adjudication Method for the Test Set

This information is not applicable to this type of device and study, as there is no human interpretation or subjective assessment that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This device is an in vitro diagnostic reagent, not an AI-powered diagnostic imaging or interpretive tool. There are no human readers involved in the direct determination of Factor VII activity using this reagent.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not directly applicable in the same way it would be for an AI algorithm. However, the performance data presented (method comparison and precision) is essentially "standalone" in the sense that it measures the performance of the device (reagent and instrument system) independently, without human interpretive input affecting the quantitative result. The device itself performs the measurement.

7. The Type of Ground Truth Used

• For Method Comparison: The measurements from the predicate devices (Hemoliance Factor VII Deficient Plasma and IL Test Factor VII Deficient Plasma) served as the comparative "ground truth" to establish substantial equivalence.
• For Precision: The known, established concentrations or expected values of the control materials (Normal Control and Low Abnormal Control) served as the ground truth against which precision (variability) was assessed.

8. The Sample Size for the Training Set

This information is not applicable. This is an in vitro diagnostic reagent, not a machine learning or AI algorithm that requires a "training set" in the traditional sense. The development of such reagents involves chemical and biological formulation and optimization, not data-driven model training.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for this type of device.

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HemosIL Factor V Deficient Plasma is human plasma immunodepleted of factor V and intended for the in vitro diagnostic quantitative determination of factor V activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems.

HemosIL Factor V Deficient Plasma is human plasma immunodepleted of factor V and intended for the in vitro diagnostic quantitative determination of factor V activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems.

Abnormalities of the extrinsic pathway factors are determined by performing a modified prothrombin time (PT) test. Patient plasma is diluted and added to a plasma deficient in factor V. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the factor V in the patient plasma, interpolated from a calibration curve.

Here's an analysis of the provided text regarding the acceptance criteria and study for the HemosIL Factor V Deficient Plasma device:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in terms of pre-defined thresholds for slope, correlation, or CV%. Instead, the implied acceptance criteria for substantial equivalence are based on demonstrating comparable performance to the predicate devices. The study data presented serves as the evidence that these implicit criteria (i.e., performance similar to predicate devices) are met.

2. Sample size used for the test set and the data provenance:

• Sample Size for Method Comparison: 60 citrated plasma samples (30 normal / 30 abnormal).
• Sample Size for Precision: Controls run over multiple runs (n=80) for each instrument.
• Data Provenance: The document does not specify the country of origin or whether the samples were retrospective or prospective. It only states "citrated plasma samples."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This device is an in vitro diagnostic reagent. The "ground truth" for Factor V activity would typically be established by the reference method (the predicate device, in this case) or a validated laboratory method using established controls.
• The concept of "experts" in the sense of clinical reviewers (e.g., radiologists) and their qualifications is not applicable to this type of device and study. The ground truth is the measured laboratory value.

4. Adjudication method for the test set:

• Not applicable. This is a comparison of quantitative laboratory measurements, not a qualitative assessment requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This is not an AI-assisted diagnostic device, nor does it involve human readers interpreting images or data. It's an in vitro diagnostic reagent.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• This is a standalone diagnostic reagent. Its performance is evaluated intrinsically through comparison to predicate devices and precision studies, without human interpretation as part of the primary diagnostic result.

7. The type of ground truth used:

• The ground truth for the method comparison study is implicitly the results obtained from the predicate devices (Hemoliance Factor V Deficient Plasma and IL Test Factor V Deficient Plasma) on their respective analyzer systems, using a common PT reagent (HemosIL RecombiPlasTin).
• For the precision studies, the ground truth for the "normal" and "low abnormal" controls would be their assigned target values (or range) based on their manufacturing and calibration processes.

8. The sample size for the training set:

• This device is a reagent and not a machine learning or AI model, so there is no "training set" in that context. The development of the reagent itself would involve formulation, characterization, and quality control, but not in the sense of a data-driven training set for an algorithm.

9. How the ground truth for the training set was established:

• Not applicable, as there is no "training set" in the context of an algorithm.

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